The present invention is directed to medicaments, compositions and methods for control, prevention, amelioration, or treatment of perspiration and topical microbial contamination or infection of skin of the hands, feet, groin, face and other areas of the body, along with reduction or control of symptoms and side effects of such perspiration and microbial contamination or infection. Such medicaments and compositions can be used in various cosmetic, medicinal and pharmaceutical products. Such medicaments also have application for athletic activities.
A range of dermatologic maladies, including inflammation, pruritus, chapping, chaffing, irritation, folliculitis, impetigo, acne, tinea, candidiasis, atopic dermatitis, contact dermatitis, eczema (acute, subacute and chronic), and seborrhea of the skin may, in many instances, be caused by a diagnosed or undiagnosed superficial infection with one or more microbes, including various bacteria, fungi and protozoa. Such microbes may be spread to other skin areas or to other individuals unless adequately controlled, and can proliferate as a result of common occupational or personal activities. Moreover, the symptoms caused by such infection may be chronic and highly resistant to conventional treatments, some of which may serve only to exacerbate the problem.
For example, increasing occupational usage of close-fitting, non-porous gloves (“protective gloves”) for prolonged periods of time (for example, by healthcare professionals, emergency response personnel, laboratory workers, security personnel, mail handlers, etc.) has been associated with a commensurate increase in localized maladies of the hands of these wearers. Moreover, prolonged usage can result in compliance problems due to perspiration of the hands that leads to glove slippage, loss of dexterity, and incomplete usage. Several examples serve to illustrate recent trends:
Concerns over possible exposure to the Human Immunodeficiency Virus (HIV) has led to establishment of strict procedures meant to protect individuals from infection with HIV, which is commonly believed to be the cause of Acquired Immune Deficiency Syndrome (AIDS). Protective gloves are now worn by medical personnel that formerly did not wear gloves (e.g., orderlies, nurses, laboratory personnel and paramedics), and these gloves are being worn for much longer periods of time than in the past. Physicians and dentists are also now required to wear protective gloves to prevent transmission of HIV. Firefighters, police and others that might come in contact with infected individuals or biological fluids are also wearing protective gloves.
Other professionals have commonly worn protective gloves during the practice of their profession prior to the onset of the AIDS crisis. Laboratory researchers and associated personnel wear gloves similar to those used by healthcare providers for prolonged periods to prevent contamination of hands by hazardous materials and to prevent samples from being contaminated with biological or other materials present on the hands.
Recent efforts aimed at heightening security have also markedly increased the use of protective gloves. For example, increased security due to possible terrorist threats have caused airlines to increase searches of passengers and their luggage. Most of the security personal conducting security searches of passengers and baggage wear disposable protective gloves. Related concern over anthrax spores sent through the U.S. postal system has led to widespread use of protective gloves by mail sorters and other Postal Service personnel.
The remarkable increase in use of disposable protective glove use is exemplified by the following statistics: in 1990, over 550 million pairs of gloves were sold in the U.S.; this number increased to an estimated 1.8 billion pairs by 1994, comprising a greater than 20% per annum growth rate. A recent estimate of the U.S. medical market for disposable gloves exceeds $1.2 billion annually. Thus, any health or compliance problems associated with protective glove use are likely to mount at a rate commensurate with the increasing number of gloves sold.
Both compliance and adverse health effects associated with long-term use of close-fitting, non-porous protective gloves appear to result from the very features intended to prevent exposure to or transfer of hazardous or undesirable agents. First, the close fit and non-porosity of the gloves increases perspiration of the hands and keeps this perspiration within the gloves. The resultant moisture within the gloves makes the gloves uncomfortable and may cause them to slip off or shift around on the hand. Slipping or shifting of gloves due to perspiration can make the manipulation of objects and the performance of complex tasks difficult. Loss of a glove or slippage of the sleeve down the hand or wrist can result in exposure of the wearer to the agents which the glove is supposed to resist; similarly, the resultant exposed skin, along with perspiration leaking from the gloves, can contaminate materials that are to be protected from exposure to human flora or secretions. Second, long-term glove usage can irritate the skin or provoke allergic reactions on the hands. Perspiration inside the gloves may exacerbate this problem. Third, increased levels of moisture on the hands may increase bacterial levels found on the hands. These bacteria can arise from normal flora of the hands themselves or from powders (e.g., cornstarch, talc) or other materials inside the gloves themselves that may contain a high number of bacteria. These proliferating bacteria can cause irritation or allergic reactions or otherwise infect the glove wearer.
Thus, prior art in protective gloves cannot cope with long-term use of gloves that chronically subjects wearers' hands to a moist, unsterile local environment. Current sales trends reflect increased use of gloves to prevent contamination with hazardous agents and widespread use by new sectors of the workforce. Nonetheless, problems related to hand perspiration and microbial proliferation in such gloves may lead to significant operator non-compliance (i.e., not wearing the gloves), potentially exposing the operator, employer, or customer to undesirable consequences (such as exposure to a serious disease like AIDS or Hepatitis B).
Furthermore, current glove technologies do not afford protection against microbial contamination (including contamination with viruses) should glove integrity be compromised. For example, if there is even a minute hole in the glove, no mechanism is available to combat microbes that might get through the barrier, thereby possibly exposing the wearer to a fatal or chronic disease.
Other undesirable skin maladies are also associated with conditions that promote or allow unchecked growth of bacteria on or within perspiring skin. For example, acne occurs when increased production of skin lipids causes the pores of the skin to close or be blocked. This causes further skin secretions (primarily perspiration and lipids) to back up within the pores. Normal flora can then proliferate in such pores, fueled by the body's own secretions of moisture (perspiration) and fuel (lipids). The body responds to this mounting bacterial load and build up of skin secretions with an inflammatory reaction, producing the hallmark acne lesions.
Current approaches to acne treatment can be highly undesirable. Analogs of normal body lipids (e.g., cis-retin A, retinol) are often used to disrupt production of skin lipids. However, cis-retin A is a powerful teratogen capable of inducing developmental abnormalities in a developing fetus or nursing infant of female patients, and may also be associated with psychotic behavior and suicide, particularly in teenage patients. In contrast, non-prescription agents (e.g., over-the-counter products, also known by the acronym OTC) approved for acne are generally ineffective. For example, a 2% solution of salicylic acid provides only a slight reduction in skin oils. Preparations based on coal tar also reduce skin oils, but are potent carcinogens when applied topically.
Other skin conditions are also produced or exacerbated by the combination of microbial infection, chronic moisture and the host's response, including tinea pedis (athlete's foot), tinea cruris (jock itch), psoriasis, seborrhea and eczema.
Thus, an effective method to simultaneously prevent proliferation of microbes and undesirable responses of the host (e.g, increased production of perspiration, lipids, or inflammatory response) without severe adverse consequences or risks is required. A product that also decreases the discomfort associated with frequent or prolonged use of disposable gloves is needed to prevent or alleviate such problems and to increase user compliance.
While there have been prior descriptions of possible uses of various antiperspirant or antimicrobial agents, it is not believed that such agents have been used or described in combination for control of skin pathogens. For example, Singleton et al. (U.S. Pat. No. 6,384,023), describes certain topical compositions for prevention and treatment of acne or seborrhea that include antimicrobial agents. Coffindaffer et al. (U.S. Pat. No. 5,624,666), describes certain topical compositions for prevention and treatment of dandruff that also include antimicrobial agents. Esser (U.S. Pat. No. 6,099,827 and U.S. Pat. No. 6,221,345), describe certain topical compositions for application as an antiperspirant. Each of these references only uses one or the other of these agents, not both. Further, no glove powder or topical handcare composition is known to Applicants to contain both antiperspirant and antimicrobial active ingredients.
Accordingly, it is an object of the present invention to overcome these prior failures and to provide methods and compositions based on such methods that control, prevent, ameliorate, or otherwise treat undesirable perspiration and topical microbial contamination or infection of skin of the hands, feet, groin, face and other areas of the body, and reduce or control of symptoms and side effects of such perspiration and microbial contamination or infection.